Incidence of bradycardia during noradrenaline or phenylephrine bolus treatment of postspinal hypotension in cesarean delivery: A randomized double-blinded controlled trial.

The treatment of choice for spinal anesthesia-induced hypotension during cesarean section is phenylephrine. As this vasopressor can cause reflex bradycardia, noradrenaline is a suggested alternative. This randomized double-blinded controlled trial included 76 parturients undergoing elective cesarean delivery under spinal anesthesia. Women received noradrenaline in bolus doses of 5 mcg or phenylephrine in bolus doses of 100 mcg. These drugs were used intermittently and therapeutically to maintain systolic blood pressure ≥ 90% of its baseline value. The primary study outcome was bradycardia incidence (<60 bpm) with intermittent bolus administration of these drugs. Secondary outcomes included extreme bradycardia (<40 bpm), number of bradycardia episodes, hypertension (systolic blood pressure > 120% of baseline value), and hypotension (systolic blood pressure < 90% of baseline value and requiring vasopressor use). Neonatal outcomes per the Apgar scale and umbilical cord blood gas analysis were also compared. The incidence of bradycardia in both groups (51.4% and 70.3%, respectively; p = 0.16) were not significantly different. No neonates had umbilical vein or artery pH values below 7.20. The noradrenaline group required more boluses than phenylephrine group (8 vs. 5; p = 0.01). There was no significant intergroup difference in any of the other secondary outcomes. When administered in intermittent bolus doses for the treatment of postspinal hypotension in elective cesarean delivery, noradrenaline, and phenylephrine have a similar incidence of bradycardia. When treating hypotension related to spinal anesthesia in obstetric cases, strong vasopressors are commonly administered, thought these can also have side effects. This trial assessed bradycardia after bolus administration of noradrenaline or phenylephrine, and found no difference in risk for clinically meaningful bradycardia.

Palonosetron versus ondansetron for prevention of nausea and vomiting after total abdominal hysterectomy under spinal anesthesia with intrathecal morphine: a double-blind, randomized controlled trial.

BACKGROUND: Hysterectomy is a widely performed surgery and neuraxial anesthesia with intrathecal morphine provides superior quality of recovery. Postoperative nausea and vomiting (PONV) is a frequent problem with intrathecal morphine use. Although palonosetron is effective for prevention of PONV after general anesthesia, its efficacy after neuraxial anesthesia has not been established. This study was conducted to compare the use of palonosetron with ondansetron for PONV prophylaxis in patients at a high risk of PONV during total abdominal hysterectomy (TAH) under spinal anesthesia with intrathecal morphine. METHODS: This prospective, randomized double-blind study conducted at São Rafael Hospital involved 140 American Society of Anesthesiologists physical status I or II women who underwent TAH under spinal anesthesia with intrathecal morphine and who had at least 3 risk factors for PONV based on Apfel's simplified score. The patients were randomized into two groups: one received palonosetron whereas the other received ondansetron. All patients received spinal anesthesia with intrathecal morphine, as well as dexamethasone plus palonosetron or ondansetron for PONV prophylaxis. The overall incidence of PONV, incidence of early- and late-onset nausea and vomiting, severity of nausea, and use of rescue antiemetics were recorded. RESULTS: The overall incidence of PONV was 42.9% in the palonosetron group and 52.9% in the ondansetron group (p > 0.05). No significant differences existed in the incidence of early- and late-onset nausea or early-onset vomiting between the two groups. The incidence of late-onset vomiting was significantly lower in the palonosetron group. CONCLUSIONS: Palonosetron exhibited efficacy similar to that of ondansetron for reducing the overall incidence of PONV after TAH under spinal anesthesia with intrathecal morphine; however, palonosetron reduced the incidence of late-onset vomiting significantly better than ondansetron. TRIAL REGISTRATION: RBR-4gnm8n ( ensaiosclinicos.gov.br ), date of registration: August 18, 2014.

Image-guided percutaneous intralesional administration of mesenchymal stromal cells in subjects with chronic complete spinal cord injury: a pilot study.

BACKGROUND AIMS: The potential of cell therapies to improve neurological function in subjects with spinal cord injury (SCI) is currently under investigation. In this context, the choice of cell type, dose, route and administration regimen are key factors. Mesenchymal stromal cells (MSCs) can be easily obtained, expanded and are suitable for autologous transplantation. Here we conducted a pilot study that evaluated safety, feasibility and potential efficacy of intralesional MSCs transplantation performed through image-guided percutaneous injection, in subjects with chronic complete SCI. METHODS: Five subjects with chronic traumatic SCI (>6 months), at thoracic level, classified as American Spinal Cord Injury Association impairment scale (AIS) grade A, complete injury, were included. Somatosensory evoked potentials (SSEP), spinal magnetic resonance imaging (MRI) and urodynamics were assessed before and after treatment. Autologous MSCs were injected directly into the lesion site through percutaneous injection guided by computerized tomography (CT). RESULTS: Tomography-guided percutaneous cell transplantation was a safe procedure without adverse effects. All subjects displayed improvements in spinal cord independence measure (SCIM) scores and functional independence measure (FIM), mainly due to improvements in bowel movements and regularity. Three subjects showed improved sensitivity to tactile stimulation. Two subjects improved AIS grade to B, incomplete injury, although this was sustained in only one of them during the study follow-up. CONCLUSION: Autologous bone marrow MSC transplantation, performed through CT-guided percutaneous injection, was shown to be safe and feasible. Further studies are required to demonstrate efficacy of this therapeutic scheme.

Children's preoperative stress according to the parental presence evaluated by salivary cortisol and mYPAS: quasi-randomized trial.

OBJECTIVE: The main objective of this study was to compare stress and anxiety levels in children undergoing surgical procedures with or without parental presence at induction of anesthesia by measuring salivary cortisol levels and applying the mYPAS. METHOD: Quasi-randomized trial with children aged 5-12 year, with ASA physical status I, II, or III, undergoing elective surgery. According to parents' willingness, the pair were defined as accompanied or unaccompanied group. Chi-square, Fisher's exact tests, Student's t test, Mann-Whitney, Hodges-Lehman and Spearman's tests were used for statistical analyzes. RESULTS: We included 46 children; 63% were preschool children mostly accompanied by their mothers (80%). The median mYPAS score was 37.5 (quartile range, 23.4-51.6) in unaccompanied children, and 55.0 (quartile range, 27.9-65.0) in accompanied children, with an estimated median difference of +11.8 (95% CI of 0 to 23.4; p = 0.044). There were no significant differences in the mean salivary cortisol levels. CONCLUSION: The level of anxiety was higher in accompanied children. There were no differences in salivary cortisol levels between both groups. Brazilian Registry of Clinical Trials (ReBEC): RBR-9wj4qvy.

Comparison between oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in autism spectrum disorder: double-blind randomized clinical trial.

BACKGROUND: Conventional dental care is often impossible in patients with Autism Spectrum Disorder (ASD). Non-collaborative behaviors, sometimes associated with aggressiveness, are usual justifications for premedication in this population. Thereby, this research focuses on the effects of oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in ASD. METHODS: The sample included 64 persons with ASD, aged 2-59 years, scheduled for dental care under general anesthesia. The primary objective of this study was to compare degrees of sedation between two parallel, double-blinded, equally proportional groups randomized to receive oral midazolam (0.5 mg.kg-1, maximum 15 mg) or oral midazolam (0.5 mg.kg-1) associated with oral S(+)-ketamine (3 mg.kg-1, maximum 300 mg). The secondary outcomes were the need of physical stabilization to obtain intravenous line, awakening time, and occurrence of adverse events. RESULTS: According to the dichotomous analysis of sedation level (Ramsay score 1 and 2 versus Ramsay ≥ 3), oral association of S(+)-ketamine and midazolam improved sedation, with increased probability of Ramsay ≥ 3, Relative Risk (RR) = 3.2 (95% Confidence Interval [95% CI] = 1.32 to 7.76) compared to midazolam alone. Combined treatment also made it easier to obtain venous access without physical stabilization, RR = 2.05 (95% CI = 1.14 to 3.68). There were no differences between groups regarding awakening time and the occurrence of adverse events. CONCLUSION: The association of oral S(+)-ketamine with midazolam provides better preanesthetic sedation rates than midazolam alone and facilitates intravenous line access in patients with autism.

Chronic pain after hospital discharge on patients hospitalized for COVID-19: an observational study.

BACKGROUND: There are few studies related to Coronavirus Disease 2019 (COVID-19) on the prevalence and nature of pain symptoms after hospital discharge, especially in individuals who develop moderate to severe disease forms. Therefore, this study aimed to evaluate the presence of chronic pain in patients discharged after hospitalization for COVID-19, and the relationship between the presence of chronic pain and intensive care stay, demographics, and risk factors for the worst Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) outcome. METHODS: A cross-sectional observational study was carried out on patients with COVID-19 who recovered after hospitalization. Patients were recruited at the least 3 months after discharge and their hospital's health files were prospected. The variables evaluated were demographics, the severity of SARS-CoV-2 infection (considering the need for intensive care), and the presence of chronic pain. The results were shown in a descriptive manner, and multivariate analysis expressed as Odds Ratios (ORs) and respective Confidence Intervals (CIs) for the outcomes studied. Statistical significance was set at p < 0.05. RESULTS: Of 242 individuals included, 77 (31.8%) reported chronic pain related to COVID-19, with no correlation with the severity of infection. Female sex and obesity were associated with a higher risk for chronic pain with ORs of 2.69 (Confidence Interval [95% CI 1.4 to 5.0]) and 3.02 (95% CI 1.5 to 5.9). The limbs were the most affected areas of the body. CONCLUSION: Chronic pain is common among COVID-19 survivors treated in hospital environments. Female sex and obesity are risk factors for its occurrence.

Intraoperative lactate levels and postoperative complications of pediatric cardiac surgery.

OBJECTIVES: Correlate arterial lactate levels during the intraoperative period of children undergoing cardiac surgery and the occurrence of complications in the postoperative period. AIM: Arterial lactate levels can indicate hypoperfusion states, serving as prognostic markers of morbidity and mortality in this population. BACKGROUND: Anesthesia for cardiac pediatric surgery is frequently performed on patients with serious abnormal physiological conditions. During the intraoperative period, there are significant variations of blood volume, body temperature, plasma composition, and tissue blood flow, as well as the activation of inflammation, with important pathophysiological consequences. METHODS/MATERIALS: Chart data relating to the procedures and perioperative conditions of the patients were collected on a standardized form. Comparisons of arterial lactate values at the end of the intraoperative period of the patients that presented, or not, with postoperative complications and frequencies related to perioperative conditions were established by odds ratio and nonparametric univariate analysis. RESULTS: After surgeries without cardiopulmonary bypass (CPB), higher levels of arterial lactate upon ICU admission were observed in patients who had renal complications (2.96 vs 1.31 mm) and those who died (2.93 vs 1.40 mm). For surgeries with CPB, the same association was observed for cardiovascular (2.90 mm × 2.06 mm), renal (3.34 vs 2.33 mm), respiratory (2.98 vs 2.12 mm) and hematological complications (2.99 vs 1.95 mm), and death (3.38 vs 2.40 mm). CONCLUSION: Elevated intraoperative arterial lactate levels are associated with a higher morbidity and mortality in low- and medium-risk procedures, with or without CPB, in pediatric cardiac surgery.

Effects of pneumoperitoneum on kidney injury biomarkers: A randomized clinical trial.

BACKGROUND: Increased intra-abdominal pressure causes hemodynamic changes that may affect renal biomarkers. METHODS: This randomized, single-blind, single-center clinical trial recruited patients undergoing laparoscopic cholecystectomy at a tertiary care center in Brazil. They were randomly allocated to a standard intra-abdominal pressure group (P10-12, 10-12 mm Hg) and a low intra-abdominal pressure group (P6-8, 6-8 mm Hg). The primary outcome was the change in neutrophil gelatinase-associated lipocalin (NGAL) and cystatin C levels measured at the beginning of the procedure (T0), at the end of the procedure (T1), and 24 hours after the procedure (T2). P-values < 0.05 were considered statistically significant. RESULTS: In total, 64 patients completed the study-33 were given standard pressure and 31 were given low pressure. There was no significant difference in the biomarker between the groups (P = 0.580), but there was a significant difference between the time points with elevation at T1 (P < 0.001). Similar to NGAL, cystatin C had an elevation at T1 in both groups (P = 0.021), but no difference was found when comparing the groups. CONCLUSIONS: In laparoscopic cholecystectomy, pneumoperitoneum increases NGAL and cystatin C levels intraoperatively, and the use of low-pressure pneumoperitoneum does not change the course of these biomarkers.

Children's preoperative stress according to the parental presence evaluated by salivary cortisol and mYPAS: quasi-randomized trial / Estresse pré-operatório em crianças de acordo com a presença dos pais avaliada por cortisol salivar e mYPAS: ensaio quase-randomizado / Estrés preoperatorio en niños según la presencia de los padres evaluado mediante cortisol salival y mYPAS: ensayo cuasi-aleatorio

ABSTRACT Objective: The main objective of this study was to compare stress and anxiety levels in children undergoing surgical procedures with or without parental presence at induction of anesthesia by measuring salivary cortisol levels and applying the mYPAS. Method: Quasi-randomized trial with children aged 5-12 year, with ASA physical status I, II, or III, undergoing elective surgery. According to parents' willingness, the pair were defined as accompanied or unaccompanied group. Chi-square, Fisher's exact tests, Student's t test, Mann-Whitney, Hodges-Lehman and Spearman's tests were used for statistical analyzes. Results: We included 46 children; 63% were preschool children mostly accompanied by their mothers (80%). The median mYPAS score was 37.5 (quartile range, 23.4-51.6) in unaccompanied children, and 55.0 (quartile range, 27.9-65.0) in accompanied children, with an estimated median difference of +11.8 (95% CI of 0 to 23.4; p = 0.044). There were no significant differences in the mean salivary cortisol levels. Conclusion: The level of anxiety was higher in accompanied children. There were no differences in salivary cortisol levels between both groups. Brazilian Registry of Clinical Trials (ReBEC):RBR-9wj4qvy.

RESUMO Objetivo: O principal objetivo deste estudo foi comparar os níveis de estresse e ansiedade em crianças submetidas a procedimentos cirúrgicos com ou sem presença dos pais na indução da anestesia, medindo os níveis de cortisol salivar e aplicando o mYPAS. Método: Ensaio quaserandomizado com crianças de 5 a 12 anos, com estado físico ASA I, II ou III, submetidas a cirurgia eletiva. De acordo com a disposição dos pais, o par foi definido como grupo acompanhado ou não acompanhado. Foram utilizados testes de qui-quadrado, exato de Fisher, t de Student, Mann-Whitney, Hodges-Lehman e Spearman para as análises estatísticas. Resultados: Foram incluídas 46 crianças; 63% delas em idade préescolar, principalmente acompanhadas por suas mães (80%). A pontuação mYPAS mediana foi de 37,5 (intervalo interquartil, 23,4-51,6) em crianças não acompanhadas e de 55,0 (intervalo interquartil, 27,9-65,0) em crianças acompanhadas, com uma diferença mediana estimada de +11,8 (IC de 95% de 0 a 23,4; p = 0,044). Não houve diferenças significativas nos níveis médios de cortisol salivar. Conclusão: O nível de ansiedade foi maior em crianças acompanhadas. Não houve diferenças nos níveis de cortisol salivar entre os dois grupos. Registro Brasileiro de Ensaios Clínicos (ReBEC):RBR-9wj4qvy.

RESUMEN Objetivo: El objetivo principal de este estudio fue comparar los niveles de estrés y ansiedad en niños sometidos a procedimientos quirúrgicos con o sin presencia de los padres en la inducción de la anestesia mediante la medición de los niveles de cortisol salival y la aplicación del mYPAS. Método: Ensayo cuasi-aleatorio con niños de 5 a 12 años, con estado físico ASA I, II o III, sometidos a cirugía electiva. Según la disposición de los padres, se definieron como grupo acompañado o no acompañado. Se utilizaron pruebas de chi-cuadrado, exacta de Fisher, t de Student, Mann-Whitney, Hodges-Lehman y Spearman para los análisis estadísticos. Resultados: Se incluyeron 46 niños; el 63% eran niños en edad preescolar, en su mayoría acompañados por sus madres (80%). La puntuación mYPAS mediana fue de 37,5 (rango intercuartílico, 23,4-51,6) en niños no acompañados y de 55,0 (rango intercuartílico, 27,9-65,0) en niños acompañados, con una diferencia mediana estimada de +11,8 (IC del 95% de 0 a 23,4; p = 0,044). No hubo diferencias significativas en los niveles medios de cortisol salival. Conclusión: El nivel de ansiedad fue mayor en los niños acompañados. No hubo diferencias en los niveles de cortisol salival entre ambos grupos. Registro Brasileño de Ensayos Clínicos (ReBEC):RBR-9wj4qvy.

Comparison between oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in autism spectrum disorder: double-blind randomized clinical trial

Abstract Background: Conventional dental care is often impossible in patients with Autism Spectrum Disorder (ASD). Non-collaborative behaviors, sometimes associated with aggressiveness, are usual justifications for premedication in this population. Thereby, this research focuses on the effects of oral midazolam versus oral ketamine plus midazolam as preanesthetic medication in ASD. Methods: The sample included 64 persons with ASD, aged 2-59 years, scheduled for dental care under general anesthesia. The primary objective of this study was to compare degrees of sedation between two parallel, double-blinded, equally proportional groups randomized to receive oral midazolam (0.5 mg.kg−1, maximum 15 mg) or oral midazolam (0.5 mg.kg−1) associated with oral S(+)-ketamine (3 mg.kg−1, maximum 300 mg). The secondary outcomes were the need of physical stabilization to obtain intravenous line, awakening time, and occurrence of adverse events. Results: According to the dichotomous analysis of sedation level (Ramsay score 1 and 2 versus Ramsay ≥ 3), oral association of S(+)-ketamine and midazolam improved sedation, with increased probability of Ramsay ≥ 3, Relative Risk (RR) = 3.2 (95% Confidence Interval [95% CI] = 1.32 to 7.76) compared to midazolam alone. Combined treatment also made it easier to obtain venous access without physical stabilization, RR = 2.05 (95% CI = 1.14 to 3.68). There were no differences between groups regarding awakening time and the occurrence of adverse events. Conclusion: The association of oral S(+)-ketamine with midazolam provides better preanesthetic sedation rates than midazolam alone and facilitates intravenous line access in patients with autism.

Pregabalin to improve postoperative recovery in bariatric surgery: a parallel, randomized, double-blinded, placebo-controlled study.

PURPOSE: Obesity has been considered as a major public health problem in developed countries for which bariatric surgery has become an important treatment strategy. Postoperative pain, however, is a frequent problem in postoperative management. Pregabalin blocks the development of hyperalgesia and central pain sensitization. The objective of this randomized, placebo-controlled, double-blinded trial was to evaluate the effect of a single dose of preoperative pregabalin vs placebo on the quality of postoperative recovery in patients undergoing bariatric surgery. PATIENTS AND METHODS: A total of 70 patients undergoing abdominal gastroplasty were randomly assigned to receive oral pregabalin (75 mg) or an identical placebo 1 hour before surgery. The primary outcome was Quality of Recovery-40 (QoR-40) score at 24 hours. Secondary outcomes included opioid consumption and postoperative pain scores. P<0.05 was considered to indicate statistical significance. RESULTS: In all, 60 of the 70 patients completed the study. The mean (SD) global recovery scores (QoR-40) 24 hours after surgery in the pregabalin and control groups were 183.7 (9) and 182.1 (12), respectively (mean difference=1.6, 95% CI -7.36 to 4.2, P=0.59). There was no significant difference in the total opioid consumption in the 24 hours following surgery between the two groups (pregabalin vs control=0.47×0.2; mean difference=0.26, 95% CI -0.24 to 0.77, P=0.3). There were no significant differences in nausea, vomiting, or time to postanesthesia care unit discharge between the two groups. CONCLUSION: In patients who underwent bariatric surgery, a single preoperative dose of pregabalin (75 mg) did not improve pain relief, quality of postoperative recovery, or reduction in opioid consumption. CLINICAL TRIAL REGISTRATION: http://www.ensaiosclinicos.gov.br (identifier: RBR-2g89x8).